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bastienjorahk

Bastien J

@bastienjorahk
4,9(3)
Stati Uniti
Inglese, Tedesco
Alcune informazioni sono riportate in lingua inglese.
Chi sono
I am a detail-oriented and results-driven professional with a focus on delivering high-quality work efficiently and accurately. I value clear communication, reliability, and building trust with every client. My goal is to provide solutions that meet your needs while maintaining professionalism and consistency.... Continua a leggere

Competenze

b
bastienjorahk
Bastien J
offline • 
Tempo di risposta medio: 1 ora

Consulta i miei servizi

Conformità e requisiti
I will provide fda compliance, fsvp and US agent services
4,9(3)
Regolamentazione per dispositivi medici
I will prepare your fda 510k premarket submission for medical devices

Esperienza lavorativa

FDA Setup

Feza • Freelance

Aug 2024 - May 2025 • 9 mos

With over 7 years of dedicated experience in US regulatory affairs and compliance, I have successfully guided medical device, pharmaceutical, and biotech formulations through critical FDA milestones. My background spans hands-on technical dossier compilation, rigorous gap analyses, and direct preparation for complex pre-submission agency interactions.

3 Recensioni
4,9

(3)
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Valutazione dettagliata
  • Livello di comunicazione del venditore
    5
  • Qualità della consegna
    5
  • Valore della consegna
    4,7
1-3 di 3 recensioni
Ordina per
Più rilevante
    S

    sebastianelia

    US

    Stati Uniti

    5

    I’m very happy with the service. The I will provide fda compliance, fsvp and us agent services was handled very well. Great attention to details and a deep understanding of FDA requirements. Everything was explained clearly and the final result was very helpful. I would definitely recommend this freelancer.

    50 USD-100 USD

    Prezzo

    3 giorni

    Tempo

    gig

    Conformità e requisiti

    Utile?
    Sì
    No
    B

    badge55

    US

    Stati Uniti

    5

    good!Very good service

    50 USD-100 USD

    Prezzo

    5 giorni

    Tempo

    gig

    Conformità e requisiti

    Utile?
    Sì
    No
    I
    image-docs

    irongoatprov

    US

    Stati Uniti

    Collaborazione in corso
    4,7

    Excellent work and very knowledgeable, answered several questions I had around some of the regulations that I was not aware of. Will add update to when we import goods and everything goes smoothly with the whole process, but FSVP was written quickly.

    200 USD-400 USD

    Prezzo

    4 giorni

    Tempo

    gig

    Conformità e requisiti

    Utile?
    Sì
    No